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The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. [1] For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study ...
The plateau principle is a mathematical model or scientific law originally developed to explain the time course of drug action (pharmacokinetics). [1] The principle has wide applicability in pharmacology, physiology, nutrition, biochemistry, and system dynamics.
The action of drugs on the human body (or any other organism's body) is called pharmacodynamics, and the body's response to drugs is called pharmacokinetics. The drugs that enter an individual tend to stimulate certain receptors, ion channels, act on enzymes or transport proteins. As a result, they cause the human body to react in a specific way.
Phase 0 trials are optional first-in-human trials. Single subtherapeutic doses of the study drug or treatment are given to a small number of subjects (typically 10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs). [43]
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may ...
Treatment can be a long process and the duration is dependent upon the patient's needs and history of substance use. Research has shown that most patients need at least three months of treatment and longer durations are associated with better outcomes. [3] Prescription drug addiction does not discriminate.
A mechanism of action usually includes mention of the specific molecular targets to which the drug binds, such as an enzyme or receptor. [3] Receptor sites have specific affinities for drugs based on the chemical structure of the drug, as well as the specific action that occurs there.
The drug must be found to be effective against the disease for which it is seeking approval (where 'effective' means only that the drug performed better than placebo or competitors in at least two trials). The drug must meet safety criteria by being subject to animal and controlled human testing. Gaining FDA approval usually takes several years.